Dive Brief:
- In a late-stage clinical trial for ITI-007, which is being investigated for treatment of schizophrenia, the 60 mg dose showed significant improvements versus placebo, although the 40 mg dose did not have a statistically significant impact.
- Another positive finding was that patients treated with ITI-007 did not significantly gain weight.
- The company's stock is up nearly another 8% in Thursday morning trading after surging on Wednesday.
Dive Insight:
Increasing dosage by 50% not only improved outcomes in ITI-007--treated patients, but resulted in statistically signficant improvements without weight gain, which is a common side effect associatThese results have led analysts to be bullish on the outlook for this drug, with Ladenburg Thalmann analyst Robert Hazlett predicting up to $2 billion annually in revenues, assuming ITI-007 is approved.
Despite the fact that there are relatively new treatments for schizophrenia available, including Johnson & Johnson's Invega, Otsuka's Rexulti and Eli Lilly's Zyprexa Relprevv, there continues to be an unmet medical need for the treatment of schizophrenia, which affects roughly 20 million people worldwide.